efficacy and safety of topical versus systemic treatment in postherpetic neuralgia and diabetic polyneuropathic pain

Conditions: Neuropathic Pain

Summary: the purpose of this study is to evaluate lidocaine as topical treatment for peripheral neuropathic pain (as stand-alone treatment and in combination with systemic treatment)


Eligibility criteria:
inclusion criteria: * male or female subjects with \>= 18 years of age * intact skin in the area of topical treatment * creatinine clearance clcr \>= 30 ml/min * nrs-3 \> 4 (recalled average pain intensity during the last 3 days) subjects with dpn * controlled, treated type 1 or 2 diabetes mellitus with glycosylated hemoglobin (hba1c)\<= 11% * painful, distal symmetrical, sensomotor polyneuropathy of the lower extremities for \>= 3 months (below the knees on both extremities) with at least 2 of the following symptoms present: burning, sensation, tingling or prickling, numbness from time to time, painful heat or cold sensation (e.g. warm or cold water) subjects with phn * subjects with phn and neuropathic pain present for \>= 3 months after healing of the herpes zoster skin rash. * without neurolytic neurosurgical therapy for their condition. exclusion criteria: general * evidence or history of alcohol, medication or drug abuse and/or dependency in the past 2 years, unstable psychological personality requiring intermittent or permanent treatment. * psychiatric illness (subjects with well-controlled depression or anxiety disorder may participate if they are not taking any of the prohibited medications defined (below), epilepsy or suicide risk. * pregnant or breastfeeding women * women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit. * subjects with severe cardiac impairment e.g. nyha class \> 3, myocardial infarction less than 6 months prior to enrollment, and/or unstable angina pectoris. * subjects with severe hepatic disorder and/or ast or alt \>= 3x the upper limit of normal. * subjects with known or suspected severe renal failure (clcr \< 30 ml/min). * anticipated need for surgery during the trial, requiring at least regional or general anesthesia. * subjects who are undergoing active treatment for cancer, are known to be infected with hiv or being acutely and intensively immunosuppressed following transplantation. * participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial. trial specific: * any concomitant use of drugs for the treatment of neuropathic pain or commonly used for the treatment of neuropathic pain. * use of transcutaneous electrical nerve stimulations (tens) after enrollment. * clcr \< 30 ml/min * evidence of another cause for pain in the area of neuropathic pain such as lumbar radiculopathy, surgery trauma, restless legs syndrome, if this coud confound the assessment or self-evaluation of the neuropathic pain. * presence of other severe pain that could confound the assessment or self-evaluation of the neuropathic pain. * history of malignancy within the past 5 years (with the exception of basal cell carcinoma). subjects with phn * active herpes zoster lesion or dermatitis of any origin at the affected site with phn. * subjects who had neurological ablation by block or neurosurgical intervention for control of pain in phn. subjects with dpn * no palpable pulse of the arteria dorsalis pedis in both feet. * clinical signs for venous insufficiency and/or postthrombotic syndrome sage iii/iv (i.e. extensive varicoses) * ulcers on the lower extremities.

Keywords: topical analgesic multiple dose